Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

Completed

• Conditions: Hemophilia B; Hemophilia A

• Registration Number: NCT04731701
• Lead Sponsor: Swedish Orphan Biovitrum

Brief Summary

The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.

Detailed Description

The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility for adult haemophilia patients.

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Study Start: 2021-05-05
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

A patient must fulfil the following criteria in order to be included in the study:

1. Age ≥18 years.
2. Diagnosis of haemophilia A or B.
3. Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French.
4. Signed informed consent.

Exclusion Criteria

The presence of any of the following criteria will exclude a patient from inclusion in the study:

1. Joint replacement within last 6 months.
2. Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
3. Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).	Baseline	Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire

Trial Locations

Locations (1)

Swedish Orphan Biovitrum Clinical site; 🇫🇷 Toulouse, France